Qualification of instruments for regulated markets has traditionally followed one of two models: paper-based protocols that are run on instruments using the native controllers of the respective instruments; and external calculations or qualification routines that are embedded into the controlling softwares of the instruments, respectively. Some efforts at automated data collection have required that an alternative data path be employed for the data collection while still controlling the instrument suing its native controller. Examples of proprietary embedded software suites include Cerity NDS (Agilent Technologies, Inc., Palo Alto, Calif. for chemical/pharmaceutical quality assurance and quality control, and Empower CDS (based on Waters Millenium software, Waters, Inc., Milford, Mass. These software suites are limited to the suite of instruments that they can control.
Thus, even though these suites are proficient for producing data and results for qualification/quality assurance tasks for the particular instruments that they control, such suites cannot provide standardization of the data types that are processed, nor calculations across controller platforms. Further, data is maintained in a proprietary format that requires the collecting data system to be present and functioning for viewing and reprocessing any data used/outputted by these systems.
Recently, an integrated single source of data collection and storage was introduced by Scientific Software (e.g., EZChrom Elite). While offering a relatively large driver set, this solution is still limited by the available drivers that are provided with the solution.
Further, all of the current solutions, including those mentioned above, as applied to instrument qualification, require decoupling of the native system that controls the instrument to be qualified, in one fashion or another.
It would be desirable to provide a solution capable of incorporating data from different instruments, as well as from different manufacturers, to compile reports thereon. It would be further desirable that such a solution provides standardization among various data types so that one platform can be readily used to generate reports using data generated from instrument having different platforms, and/or still other instruments that aren't included with any established platforms. Accordingly, there is a need for solutions that are generally applicable for use with data generated/collected by instruments from most, if not all manufacturers, to readily prepare reports therefrom and/or otherwise manipulate the data as needed